MICONAZOLE NITRATE- antifungal miconazole powder jock itch spray aerosol, powder

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole nitrate 2%

​ ​Purpose

Antifungal

Uses

• cures most jock itch (tinea cruris)
• relieves symptoms of jock itch including itching, burning and chafing associated with jock itch

​Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF.

​When using this product

• do not get into eyes or mouth
• use only as directed

Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

​Stop use and ask a doctor if

• irritation occurs
• no improvement within 2 weeks

​Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor. 

​Directions

• wash affected area and dry thoroughly
• shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product
• use daily for 2 weeks; if conditions persist, consult a doctor
• in case of clogging, clear nozzle under running water
• this product is not effective on scalp or nails

​Other information

store between 20º and 30ºC (68ºF and 86º)

​Inactive ingredient

isobutane (propellent), SD alcohol 40-B (14%w/w), stearalkonium hectorite, talc

​Questions?

Call 1-866-964-0939

Principal Display Panel

Premier

Medicated
Jock Itch
Powder Spray
Miconazole Nitrate 2%

• Cures most jock itch
• Relieves itching, chafing, & burning

NET WT 4.6 FL OZ (130g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
antifungal miconazole powder jock itch spray aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2.6 g  in 130 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE (UNII: BXR49TP611)
ALCOHOL (UNII: 3K9958V90M)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-301-46	130 g in 1 CANISTER; Type 0: Not a Combination Product	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2013

Labeler - Premier Brands of America Inc. (080051232)